Time-Sensitive / Site Specific Roll-Out of Protocol
Most clinical trials require protocol amendments.
EDCPRO includes a set of tools to enable planning,
testing and roll-out of protocol amendments without
interrupting the study or database down-time. The
protocol amendment are fully integrated into the Schedule of
Assessments, data validation system, and protocol guidance
The following changes to the database are supported in
- Changes to field/variable names, labels, input options, and
help in existing forms;
- Adding and/or removing fields/variables in existing
- Adding and/or removing visits;
- Adding and/or removing assessments/forms to a scheduled
- Adding new assessments/forms.
Changes are deployed to the open database and synchronized with
all previous amendments and previously reported data. Tools
are provided to deploy the changes to:
- All study subjects retroactively;
- Newly enrolled subjects only;
- Newly reported data only.
In addition, the flexibility of EDCPRO means that the
following major protocol changes can be handled with ease and
- Changing enrolment criteria;
- Changes to the randomization / treatment allocation
Protocol amendments are transparent to study sites meaning that
sites with IRB approval of the amendment are managed according to
the new protocol (with access to the revised eCRFs) while other
sites continue working under the prior protocol until approval.